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510(k) Data Aggregation

    K Number
    K072534
    Device Name
    BIO-MAT 2000
    Manufacturer
    RICHWAY INTL., INC.
    Date Cleared
    2008-02-08

    (154 days)

    Product Code
    IRT
    Regulation Number
    890.5740
    Why did this record match?
    Applicant Name (Manufacturer) :

    RICHWAY INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bio-Mat is indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis; the temporary relief of muscle spasms, minor sprains and strains, and minor muscular back pain; the relaxation of muscles; and the temporary increase of local circulation where applied.
    Device Description
    The Bio-Mat is an electrically powered mattress pad that applies infrared heat to the user's body for the temporary relief of minor body aches and pains. A control panel allows the user to turn the product on/off, modify the temperature, and set the product's timer.
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